Providing administration of an active agent, such as a pharmaceutical active, in an oral film form is known to have substantial benefits over other dosage forms, such as tablets and the like. Generally, such oral films include a mixture of a polymer, solvent, the active, and flavorants, such as sweeteners and other flavor-enhancing components. A wet matrix of the components is prepared and then dried into a film dosage form.
In preparing such film dosage forms, uniformity of content of the film-forming matrix is important, so as to provide an even level of the active in individual film dosages. To achieve a uniform and even dispersion of components, it may be desired use a multi-step mixing process, where certain components are first mixed together, and then added to a third component. When various components are added to a polymer solution, it is beneficial that the components not form a gelatinous or plastic-like mass prior to addition to the polymer solution. As is readily understood by one of skill in the art, when the various components have such gelatinous composition, uniform and even dispersion throughout the polymeric matrix is difficult, if not impossible. It has been surprisingly discovered that the combination of certain actives and sweeteners has a tendency to result in an undesirable gel-like mass, which may be difficult to uniformly distribute throughout a polymeric matrix. Furthermore, it is difficult or impossible to spread a gel-like mass on to a substrate to produce a wet film for subsequent drying to form the dried film.
The present invention seeks to provide a method and system for preparing film dosages that overcomes the disadvantages in the prior art.